Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/14—Bandages or dressings; Absorbent pads specially adapted for the breast or abdomen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
  • A61M1/91—Suction aspects of the dressing
  • A61M1/917—Suction aspects of the dressing specially adapted for covering whole body parts

Definitions

• devices and methods for reducing edema at target sites using negative pressure and/or therapeutic agents are disclosed.
• the target site is associated with a breast of the subject.
• the treatment device is sized and shaped to be placed on at least one breast of the subject.
• the plurality of surface patterns are shaped to contour to the at least one breast of the subject.
• a treatment device is secured to both breasts of the subject.
• the plurality of surface patterns comprises a plurality of embossed structures.
• the target site is associated with a lower leg of the subject. In particular embodiments, the target site is associated with a foot of the subject. In some embodiments, the target site is associated with an arm of the subject. In particular embodiments, the target site is associated with a hand of the subject. In some embodiments, the target site is associated with a chest of the subject. In some embodiments, the target site is associated with an abdomen of the subject.
• the chamber is constructed and configured to enclose a target site on the subject experiencing edema.
• the at least one conduit is configured to remove fluid from, or introduce fluid to, the treatment space.
• the plurality of surface patterns are shaped to contact and contour to the target site.
• the plurality of surface patterns may be positioned at a distance of about 0.2 mm to about 10 mm apart from one another and may have a height of about 0.1 mm to about 5 mm.
• the plurality of surface patterns is positioned in a uniform pattern on the inner surface of each chamber. In some embodiments, the plurality of surface patterns is positioned in a non-uniform pattern on the inner surface of each chamber.
• each of the plurality of surface patterns has a shape selected from the group consisting of a cone, a pyramid, a pentagon, a hexagon, a half sphere, a dome, a rod, an elongated ridge with round sides, and an elongated ridge with square sides.
• the plurality of surface patterns intrude into the isolated treatment space in a direction generally perpendicular to the inner surface of the chamber. In certain embodiments, the plurality of surface patterns comprises a plurality of embossed structures.
• the edema management device may comprise a suction device for applying the negative pressure, a fluid trap, and an exhaust port, wherein the suction device is in fluid communication with the treatment space of each chamber, the fluid trap and the exhaust port, and wherein the fluid trap is fluidly positioned between the suction device and the exhaust port.
• the target site is associated with the breast of the subject. In some embodiments, the target site is associated with a lower leg of the subject. In particular embodiments, the target site is associated with a foot of the subject. In some embodiments, the target site is associated with an arm of the subject. In particular embodiments, the target site is associated with a hand of the subject.
• an edema management device for at least one breast of a subject may comprise a chamber having an inner surface defining a treatment space sized and shaped to enclose at least one breast, the inner surface comprising a plurality of surface patterns configured to directly contact the at least one breast and to create pathways for distributing a negative pressure between the inner surface and the at least one breast; a sealing portion at a base of the chamber configured to be secured to the skin of the chest wall around the at least one breast, the sealing portion comprising an adhesive; and at least one conduit having a first end and a second end, the first end connected to the chamber and in fluid communication with the treatment space so as to enable applying a negative pressure to the treatment space.
• the chamber is sized and shaped to enclose both breasts of the subject.
• the chamber is configured to provide support to the at least one breast when a negative pressure is applied.
• the chamber is associated with an undergarment configured to provide support to the at least one breast.
• the undergarment may include an outer supporting structure, such as a pouch or pocket, that encloses the chamber.
• the outer supporting structure is a fabric material.
• the chamber is fabricated from a substantially impermeable material.
• the at least one conduit is configured to remove fluid from, or introduce fluid to, the treatment space.
• each of the plurality of surface patterns has a shape selected from the group consisting of a cone, a pyramid, a pentagon, a hexagon, a half sphere, a dome, a rod, an elongated ridge with round sides, and an elongated ridge with square sides.
• the plurality of surface patterns intrude into the isolated treatment space in a direction generally perpendicular to the inner surface of the chamber.
• the chamber does not include a porous insert.
• FIG. 1 is a perspective view of a treatment device with a conduit leading from a chamber to a suction source;
• FIG. 6 is a side sectional view of a plurality of surface patterns disposed on and into the inner surface of the chamber wall, where the plurality of surface patterns are of uniform size and shape, and are spaced uniformly apart;
• FIGS. 6a, 6b, and 6c present schematics of a plurality of surface patterns in accordance with one or more embodiments
• FIG. 7 is a side sectional view of two groups of surface patterns disposed on and into the inner surface of the chamber wall, where one group intrudes into the treatment space, the other group intrudes to a lesser extent, and surface patters from these groups alternate in a regular patter;
• FIG. 8 is a side sectional view of three groups of surface patterns disposed on and into the inner surface of the chamber wall, where such groups have varying degrees of intrusion into the chamber space and alternate in a regular pattern;
• FIG. 9a is an overview of surface patterns disposed on and into the inner surface of the chamber wall, where the structures consist of raised ridges;
• FIG. 10 is an overview of the raised ridge surface patterns shown in FIG. 9a, with the addition of raised dome surface patterns positioned among the ridges;
• FIG. 16 is a view of a sub-branching pattern of channels leading to the communicating conduit
• FIG. 21 is a sectional view of a suction device in the form of a squeeze bulb of deformable material
• FIG. 32 is an exploded schematic side view of an exudate collection device in accordance with one or more embodiments.
• the device may contact the target site directly, without the use of an interface layer such as a porous insert.
• the device may be used in conjunction with a therapeutic agent, such as an immediate release or sustained-release therapeutic agent.
• the therapeutic agents may be formulated as described further herein, such as with a biomaterial.
• the biomaterial may be naturally occurring and biocompatible.
• the biomaterial may be cross-linked with the therapeutic agent.
• the biomaterial may be selected based on its properties.
• the biomaterial may be, for example, a hydrogel, a hydrocolloid, alginate, or any other gel.
• a patient may have a total body surface area (TBSA) injury of about 5% to about 30% or greater.
• the target site comprises a wound site.
• the wound site may be a bilateral wound.
• the wounds may be acute or chronic.
• deep dermis, subcutaneous tissue, muscle, fascia, tendon or bone may be exposed due to the nature of the target site.
• the devices and methods may be used anywhere on the human body and may also be suitable for veterinary applications.
• treatment sites that are suitable for use with devices of the invention include, but are not limited to, treatment sites associated with the breasts, the lower leg, e.g., foot, the arm, e.g., hand, the chest, and the abdomen.
• the devices and methods may, for example, be used for target site preparation to prevent scarring as well as the fixation and protection of skin grafts during treatment.
• treatment may relate to injuries occurring on the head, face, and/or neck.
• a patient for example, a patient’s cheeks, forehead, and/or crown may be treated.
• the head including facial tissue presents unique challenges which may be addressed in accordance with one or more embodiments.
• edema and incision management may occur at or near at least one breast, such as after a cosmetic procedure or a surgical procedure, such as a mastectomy.
• the edema management device may be placed on a wound site resulting from a surgical procedure, such as a sternotomy, thoracotomy, laparotomy, or the donor site of a full-thickness skin graft.
• Alginate may be used in various formulations of therapeutic agent(s) to achieve an acceptable viscosity range. Relatively high viscosity may be a desirable property to facilitate treatment, as well as relatively low freezing point.
• combination and/or serial treatment regimens may be practiced.
• the devices may be applied after hemostasis.
• a target site may be debrided for a period of time, and then subjected to treatment with the devices and formulated therapeutic agents described herein.
• the disclosed therapeutic agents may be left in place on the target site for up to a week or more prior to further evaluating the target site to discern further treatment steps.
• the target site may be left in the sterile environment of the disclosed devices for extended periods of time to facilitate healing.
• the formulated therapeutic agents also promote relatively uninterrupted periods of target site therapy.
• periods of negative pressure target site therapy may be applied to the target site via the disclosed devices as described herein.
• the end of the conduit 32 extending into the chamber space 24 is shown with multiple holes 44.
• the purpose of the holes 44 is to ensure that gases, liquids, fluid, debris, and other materials can flow and move out of the treatment space 24 into the conduit 32 without impediment.
• the target site may advantageously be monitored through the substantially transparent chamber material.
• the negative pressure device 20 may also be equipped with sensors to monitor certain parameters within the chamber space 24. For example, oxygen, carbon dioxide, pH, temperature, and other parameters may be measured and monitored.
• FIG. 11 is an overview of a portion of the chamber wall, showing a plurality of surface patterns 47 arranged in two parallel lines to form a channel 49.
• FIG. 12 shows a channel 49 formed by two parallel lines of raised domed structures 48.
• Such channels can be configured in various patterns, such as radial, circular, concentric, or branching.
• FIGS. 13- 16 show overviews of patters of channels 49 leading from tube 32 along the interior surface of chamber 22 facing treatment space 24.
• the channel 49 defines a space that opens directly to the treatment space 24. The space preferably opens to the treatment space 24 over the entire length of the channel 49.
• FIG. 19 shows a treatment device 120 for delivering negative pressure and therapeutic substances in the form of a cylinder that can be placed over a limb.
• the treatment device 120 includes an open end and a closed end, though the chamber may have other shapes to accommodate other body parts, and may for example, be suitable for fitting over the head.
• the open end is preferably sealed with a cuff or collar (not shown), and the open end may include adhesive on the interior surface that defined a sealing portion.
• the treatment device 120 includes a plurality of surface patterns 40 and channels 49 on the interior surface of the chamber wall.
• FIG. 25 is a sectional view of a trap 80 and a filter 82 interposed between the suction device 34 and the exhaust valve 62 for the purpose of preventing the expulsion of liquids or aerosols from the suction device.
• a view of a fluid collection device 300 is provided.
• the device is intended to receive fluid, debris, exudate, or other materials removed from a target site during treatment or therapy and store such materials for eventual disposal.
• the device includes a compartment 310 defining a collection space.
• the compartment has a pillow-shaped configuration.
• the invention is not so limited, and other configurations of a compartment formed of a flexible, substantially moisture and gas impermeable material may be used. The use of an impermeable material is particularly advantageous for preventing fluid loss from the compartment.
• Materials from which the device may be made vary.
• the collection device chamber may be made of the same material as the treatment device chamber.
• the device can be designed for use with any treatment device as described herein and on any body part, including both human and veterinary applications.
• Various geometries such as spherical, cubic, parallelepiped, tubular, pouch, envelope or other shapes may be implemented based on the intended application.
• FIG. 31 is a schematic side view of a fluid collection device in accordance with one or more embodiments. It is illustrated that a piece of material can be folded and sealed on the remaining three sides around the perimeter to form the collection device.
• FIG. 32 is an exploded schematic side view of a fluid collection device in accordance with one or more embodiments. FIG. 32 illustrates that compartment 7 may include both a cotton material as well as a laminate absorbent sheet. Check valve (one-way) 10 prevents back flow to the treatment device and transducer 3 serves as a safety measure as described above.
• Check valve (one-way) 10 prevents back flow to the treatment device and transducer 3 serves as a safety measure as described above.
• the treatment device chamber may generally involve a degree of convexity or concavity to enable it to be pulled down, for example, into contact with a deep or full thickness wound, such as upon application of negative pressure.
• FIG. 33a illustrates the concavity of a treatment device chamber.
• the treatment device chamber concave with respect to the device as applied, has a target site periphery area 330, which is placed over the periphery of the target site.
• a plurality of surface patterns 40 interface with the target site surface during use of the device. The plurality of surface patterns may directly contact the target site surface.
• the concavity of the treatment device chamber may be desirable in certain cases such as when the target site is a deep wound, for example a puncture.
• a treatment device chamber has a concave superstructure 350.
• the concavity of the superstructure of the device may provide folds that extend into the deep part of the target site to create channels for air and fluid flow.
• FIGS. 36a and 36b show a treatment device 20 for delivering negative pressure, and optionally therapeutic substances, having the form of two breast shaped chambers 22 that are sized to sit on the breasts of a subject and define a treatment space 24 therein. As shown in FIG.
• each chamber 22 is sized and shaped to closely match the breast of the subject and has a sealing portion that secures the chamber to the skin around and underneath the breast.
• the dots in FIGS. 36a and 36b correspond to a plurality of surface patterns 40 that can directly contact the tissue of the breast as described herein.
• Each chamber has a conduit 32 that provides fluid access to the treatment space 24 of each chamber 22. As shown in FIG. 36a, the second end of each conduit 32 is connected to a Y-shaped fitting 33 that merges the independent fluid paths into one path for connection to a fluid container and a suction source 34.
• the treatment device includes a chamber defining a treatment space, the chamber being fabricated from a substantially impermeable material and configured to conform to the shape of the periphery, an inner surface of the chamber including a plurality of surface patterns, the chamber having a sealing portion at a base, and at least one conduit connected to the chamber and in fluid communication with the treatment space so as to enable the application of a negative pressure to the treatment space.
• the target site may be a wound site, and can be associated with a breast, lower leg, e.g., a foot, or arm, e.g., a hand, of a subject.
• the device When associated with a breast of subject, the device may be sized and shaped to be placed on at least one breast and the surface patterns are shaped to contour to the at least one breast of the subject.
• the treatment device may be secured to both breasts of the subject.
• a swine study was conducted. Up to 14 partial-thickness bums were created on the dorsum of each pig. Subsequently, the bum wounds were infected with S. aureus, P. aeruginosa, A. baumannii, or C. albicans and then treated individually for 7 days with 1000xMIC of topical vancomycin, gentamicin, minocycline or lOxMIC of topical DIFLUCAN®, respectively, formulated in a 0.625% alginate hydrogel. A treatment device as described herein was used in conjunction with the antibiotic treatment.
• aeruginosa infected bums 1000xMIC gentamicin hydrogel reduced bacterial counts more efficiently than SILVADENE® cream (p ⁇ 0.01), blank hydrogel (p ⁇ 0.01), dry control (p ⁇ 0.01) and IV minocycline.
• FIG. 34c in S. aureus infected wounds, 1000xMIC minocycline hydrogel reduced bacterial counts in the burnt tissue more efficiently than SILVADENE® cream (p ⁇ 0.01) and IV minocycline (p ⁇ 0.01).
• FIG. 34d in C. albicans infected wounds lOxMIC DIFLUCAN® hydrogel reduced bacterial counts in the burnt tissue more efficiently than dry control (p ⁇ 0.01) and IV DIFLUCAN® (p ⁇ 0.01).
• Rheology data pertaining to the 0.625 % alginate hydrogel is presented in FIG. 35c.
• homogenized hydrogels were analyzed via shear rate sweeps to calculate the viscosity, as an indication of injectability.
• the geometry used was rough-surfaced 1° 40mm Cone-and-Plate at a gap of 400 ⁇ m.
• Storage modulus and loss modulus data pertaining to the 0.625 % alginate hydrogel is presented in FIG. 35d.
• the storage modulus is larger than the loss modulus, indicative of a gel, and not a viscous liquid. Also, the moduli are relatively low, demonstrating that it is a very soft hydrogel.
• a strain sweep is used to determine the linear- viscoelastic area of the hydrogel, and a frequency sweep is used to determine the linear equilibrium modulus plateau of the hydrogel.
• a treatment device as described herein was utilized on closed incision surgical wounds from differing procedures on a large patient population to investigate in a clinical setting the efficacy of the treatment device.
• Negative-Pressure Platform Wound Dressing (NP-PWD)
• NP-PWDs (Applied Tissue Technologies LLC, Hingham, MA) were used with the INVIA® Motion NPWT pump (Medela, Baar, Switzerland) at -80 mm Hg continuous pressure in the study. A negative pressure tube was connected to each PWD and to the negative pressure pump. Oblong NP-PWD with wound openings measuring 1” x 3” (Part no. AT1073-01) and 3” x 5” (Part no. AT1074-01) were utilized in this study (FIG. 37).
• the NP-PWD was applied using sterile techniques. Excess hair adjacent to the wound was removed with a razor prior to application. The backing on the underside of the NP-PWD was then removed and the dressing was gradually applied so that the center of the NP-PWD was directly over the center of the wound and the adhesive in contact with intact skin surrounding the wound.
• the INVIA® motion pump, collection canister, and tubing were then assembled, and the pump securely connected to the NP-PWD. The pump was then powered on and negative pressure set to -80 mm Hg.
• the NP-PWD was removed at the first post-operative check (POC) between postoperative days (PODs) 3-5. Patients were required to undergo an additional POC between PODs 9-14.
• POCs consisted of incision assessment, measurement, photography, and adverse event (AE) screening. Assessments specifically addressed erythema, drainage, itching, and pain at the incision site. At each POC, two members of the study team indicated presence or absence of the above physical exam findings. The same study members assessed the incisions at each time point to maintain consistency. Evaluation of erythema and drainage were made qualitatively by members of the study team while assessment of itching and pain were made based on patient reports. Incision measurements were recorded in centimeters at each POC by members of the study team. A digital photograph of each wound was obtained at each POC as well. All AEs were recorded and assessed for relation to the NP-PWD. Results
• FTSG full-thickness skin graft
• This study examined the use of the NP-PWD in a clinical setting.
• the dressing was applied onto a variety of closed surgical incisions following operations to different areas of the body including the breast, chest or chest walls, abdomen, and groin. No wound infection occurred during this study.
• the patients included in this study had significant comorbidities, including diabetes and active malignancies, that are known to impair wound healing.
• the dressing was easy to apply by the clinical staff, patients did not report any intolerable side effects, and incisions healed well without signs of infection or dehiscence. In the case of the blisters that developed under the adhesive of two incisions, this was more likely to be due to incision location (panniculectomy) and patient factors as opposed to the device itself.
• the NP-PWD devices disclosed herein remedy the deficiencies of currently available negative pressure wound care devices.
• the time to cut the foam to the shape of the wound is significant.
• the opacity of the foam within current devices prevents assessments while the devices are in place and can serve as a nidus for infection or interrupt the formation of healthy granulation tissue upon removal.
• Current negative pressure wound care devices require relatively high negative pressure settings to reach therapeutic levels of negative pressure on the wound bed. High negative pressure levels can result in discomfort for the patient and even lead to ischemia of wounds that are already poorly vascularized.
• NP-PWD devices addresses those limitations by providing an easy-to-apply, transparent, foam-less dressing that can be placed in the OR and removed within days after incision creation.
• the NP-PWD devices disclosed herein provide a novel closed incision negative pressure therapy (NPT) that provides an easy-to-apply, transparent, foam-less dressing that can be placed in the OR and removed within days after incision creation.
• NPT closed incision negative pressure therapy
• the goal of this study will be to determine the efficacy of using a treatment device in conjunction with formulated high-dose therapeutic agents as described herein to ease pain and reduce or eradicate infection as compared to the standard of care dressing in human patients.
• a large but safe dose (1000 x MIC) of an antibiotic and analgesic in a gel will be used to immediately treat patients with traumatic extremity wounds and bums (total body surface area of 5 to 30%).
• the devices will be left in place for at least 48 and up to 96 hours at which time it will be removed and the wound cultured and debrided.
• the antibiotic and analgesic concentrations in the gel/fluid within the devices as well in the serum will be measured every 24 hours.
• CFU Quantitative bacterial counts
• references to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms. Any references to front and back, left and right, top and bottom, upper and lower, and vertical and horizontal are intended for convenience of description, not to limit the present devices and methods or their components to any one positional or spatial orientation.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Vascular Medicine (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Surgical Instruments (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Accommodation For Nursing Or Treatment Tables (AREA)

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• 2021
  • 2021-01-08 CA CA3164156A patent/CA3164156A1/en active Pending
  • 2021-01-08 JP JP2022542179A patent/JP2023509955A/ja active Pending
  • 2021-01-08 WO PCT/US2021/012739 patent/WO2021142293A1/en not_active Ceased
  • 2021-01-08 US US17/790,432 patent/US20230079448A1/en active Pending
  • 2021-01-08 EP EP21738533.5A patent/EP4087629A4/en not_active Withdrawn
  • 2021-01-08 AU AU2021205498A patent/AU2021205498A1/en not_active Abandoned

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